chronOS Inject in Proximal Tibial Fractures

NCT ID: NCT02056834

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-01
• Study Completion Date: 2012-09-30

Brief Summary

The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.

Detailed Description

The primary objective of this study was to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures. Secondary objectives were to assess the surgeon's satisfaction in using chronOS Inject and patient satisfaction post surgery.

The study was planned to be a multi-center, prospective, observational study. Patients with proximal tibial fractures of type Schatzker I - VI, AO-Müller-Orthopaedic Trauma Association (AO-OTA) 41, AO-OTA 42 with bone defect were assessed for eligibility to enter the study. Patients eligible for the study were followed over time to twelve months after surgery.

Conditions

Closed Proximal Tibial Fracture Schatzker I - VI; Closed Proximal Tibial Fracture AO-OTA 41; Closed Proximal Tibial Fracture AO-OTA 42

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

chronOS Inject

Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect

chronOS Inject

Intervention Type: DEVICE

chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures

Interventions

chronOS Inject

chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects with closed proximal tibial fractures defined by : Tibia plateau, Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
• Skeletally mature adult 18 years or older, with close of growth plate at the time of surgery
• Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
• Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study

Exclusion Criteria

• Open fractures with severe soft tissue damage
• Proximal tibial fractures with tumor or osteomyelitis
• Any tibial anatomy or disease process that would interfere with deployment or performance of the device as defined by the surgeon
• Osteopenia or Osteoporosis: if dual energy x-ray absorptiometry (DEXA) is required, exclusion will be defined as a DEXA bone density measured T score <=-1.0
• Known history of Paget's disease, osteomalacia, or any other metabolic bone disease
• Morbid obesity defined as a body mass index >40 kg/m2 or weight more than 50 kg over ideal body weight
• Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy >5 years
• Known or documented history of communicable disease, including AIDS and HIV
• Active Hepatitis (receiving medical treatment within two years)
• Active systemic or local infection
• Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing
• Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol)
• Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for >1 month within last 12 months
• Pregnant or planning to become pregnant during study period
• Involved in study of another investigational product that may affect outcome
• History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales
• Patients who are incarcerated

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chang-Wug Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Kichul Park, MD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

Kyungpook National University Hospital

Daegu, , South Korea

Hanyang University Guri Hospital

Guri-si, , South Korea

Countries

South Korea

Other Identifiers

STU-BIO-T-XX-004-04

Identifier Type: -

Identifier Source: org_study_id